Patient leaflet - ZEMPT 60 MG MODIFIED RELEASE TABLETS, TILDIEM 60 MG MODIFIED RELEASE TABLETS
Package Leaflet: Information for the User
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes possible side effects not listed in this leaflet. See section 4.
- The name of this medicine is Tildiem® 60mg Modified Release Tablets but will be referred to as Tildiem throughout the remainder of this leaflet.
-
1. What Tildiem is and what it is used for
-
2. What you need to know before you take Tildiem
-
3. How to take Tildiem
-
4. Possible side effects
-
5. How to store Tildiem
-
6. Contents of the pack and other information
1. what tildiem is and what it is used for
Tildiem contains a medicine called diltiazem hydrochloride. This belongs to a group of medicines called ‘calcium-channel blockers’. It works by making your blood vessels wider, which makes it easier for your heart to pump blood around the body. This helps to prevent the chest pain caused by angina.
Tildiem is used for:
- Angina (chest pain)
- Stopping you getting angina in the future
2. what you need to know before you take tildiemdo not take this medicine if:x you are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of tildiem (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
X You are breast-feeding or planning to breast-feed (see below: ‘Pregnancy and breast-feeding’).
X You are having a medicine called dantrolene used for severe muscle spasms or severe fever (see below: ‘Other medicines and Tildiem’).
X You have a very slow heartbeat – less than 50 beats per minute.
X You have heart failure and problems with blood flow to your lungs.
With these illnesses, you may feel out of breath and have swollen ankles.
X You are already taking a medicine containing ivabradine for the treatment of certain heart diseases.
X You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker).
X You are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels. (see section: ‘Other medicines and Tildiem).
X You are already taking a medicine containing asunaprevir used for the treatment of hepatitis C virus infection. (see section: ‘Other medicines and Tildiem).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tildiem.
Warnings and precautions
Talk to your doctor or pharmacist before taking your medicine if: a You have a history of heart failure, new shortness of breath, slow heartbeat or low blood pressure. Cases of kidney injury in patients with such conditions have been reported.
a You have any other problem with your heart, apart from angina or those described in the previous section.
a You are going to have an operation.
a You are at risk of mood changes, including depression.
A You are at risk of gut problems.
Your doctor will check you more closely particularly when you first start taking the tablets if:
a You are over 65 years old.
a You have liver or kidney problems.
a You have diabetes.
a You have or ever had asthma.
a You take any beta blocker medicines.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tildiem.
Other medicines and Tildiem
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines you buy without a prescription, including herbal medicines. This is because Tildiem can affect the way some other medicines work. Also some medicines can affect the way Tildiem works.
In particular, do not take this medicine and tell your doctor if you are taking:
- Dantrolene (an infusion) used for severe muscle spasms or severe fever (called ‘malignant hyperthermia’).
- Medicines containing ivabradine used for the treatment of certain heart diseases.
- Medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of the lomitapide that may lead to an increase in the likelihood and severity of liver related side effects.
- Medicines containing asunaprevir used for the treatment of hepatitis C virus infection. Diltiazem may increase the concentration of the asunaprevir that may lead to an increase in the likelihood and severity of liver related side effects.
- Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol.
- Medicines used for an uneven heartbeat such as amiodarone and digoxin.
- Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate.
- Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin.
- Ciclosporin used to stop the rejection of organs after a transplant.
- Phenytoin and carbamazepine used for epilepsy.
- Antiplatelet medicines used to reduce the chance of blood clots forming, such as aspirin or clopidogrel.
- Iodinated contrast media (used for tests involving X-rays).
- Theophylline used for breathing problems.
- Lithium used for some types of mental illness.
- Medicines used for sleeplessness or anxiety, such as triazolam or midazolam.
- Methylprednisolone used for inflammation.
- Cilostazol used for intermittent cramp-like pain in your legs when you walk caused by insufficient blood supply in your legs.
- Rifampicin used for tuberculosis.
- Medicines for stomach ulcers such as cimetidine and ranitidine.
Tildiem with food and drink
It is advisable to limit the amount of grapefruit juice you drink while taking Tildiem as it can increase the blood levels of the active ingredient diltiazem and may increase your chance of getting side effects. If you are concerned you should stop drinking grapefruit juice and consult your doctor.
Pregnancy and breast-feeding
- You should not take Tildiem if you are pregnant, might become pregnant or think you may be pregnant. This is because Tildiem can cause problems for your baby. Talk to your doctor if you might be pregnant.
- Do not breast-feed if you are taking Tildiem. This is because small amounts may pass into mother's milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.
Tildiem contains:
- Lactose. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
- Hydrogenated castor oil. May cause stomach upset and diarrhoea.
3. how to take tildiem
Always take Tildiem exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Take this medicine by mouth.
- If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
- The usual dose is one tablet three times a day.
- Two tablets three times a day or
- Two tablets four times a day.
- The usual dose is one tablet twice a day.
- Tildiem should not be given to children.
If you take more Tildiem than you should
If you take more tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, shortness of breath, fainting, an unusually fast or slow heartbeat, slurred speech, confusion, coma, sudden death and decrease of kidney function.
If, in an emergency situation, the patient is treated quickly sudden death is not only the potential outcome.
If you forget to take Tildiem
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Tildiem
Keep taking Tildiem until your doctor tells you to stop. Do not stop taking them just because you feel better. If you stop, your illness may get worse.
Tests
Your doctor may do regular tests while you are taking this medicine. These might include a check on your heart and blood tests to check on your liver and kidneys.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Tildiem can cause side effects although not everyone gets them.
Stop taking and see a doctor or go to a hospital straight away if: Frequency unknown (cannot be estimated from the available data)
- You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
- You have a red or lumpy skin rash, swollen eyelids, face, lips, throat, or tongue, difficulty in swallowing.
- Your asthma gets worse.
- You have difficulty breathing, wheezing, tightness in the chest (called ‘bronchospasm’).
- You get blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be an illness called ‘Stevens-Johnson syndrome’.
- You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may feel generally unwell and have a fever, chills and aching muscles. This could be an illness called ‘Toxic Epidermal Necrolysis’.
- You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme’.
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment: Common (affects less than 1 in 10 people)
- Slow or uneven heartbeat
- Very fast, uneven or forceful heartbeat (palpitations)
- Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’).
- Being short of breath, feeling tired along with swollen ankles and legs. This could be signs of heart failure.
- Unusual movements of the tongue, muscle spasms in your face, rolling eyes and trembling.
- High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (called ‘hepatitis’).
- Passing large amounts of urine, excessive thirst and having a dry mouth or skin. These may be signs of high blood sugar (hyperglycaemia).
- Get sunburnt easier, and which may be more severe than in someone not taking Tildiem. You should use sun protection whilst taking this medicine.
- Breast enlargement in men.
Tell your doctor as soon as possible if you have any of the following side effects:
Very common (affects more than 1 in 10 people)
- Swelling of the lower legs
- Indigestion, stomach pain, constipation and diarrhoea
- Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure)
- Dry mouth
- Itchy, lumpy rash (called ‘urticaria’)
Frequency unknown (cannot be estimated from the available data)
- Swollen gums
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (affects less than 1 in 10 people)
- Headache
- Flushing (feeling of warmth)
- Feeling sick (nausea) or being sick (vomiting)
- General feeling of being unwell
- Weakness or tiredness
- Feeling dizzy
- Skin redness
- Difficulty sleeping
- Mood changes, including depression
- Bleeding or bruising under the skin
Blood tests
Tildiem can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
Manufactured by
Sanofi Winthrop Industrie, 30–36 Avenue Gustave Eiffel, Tours, France.
Procured from within the EU by the Product Licence Holder: MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0682
POM
This leaflet does not contain all the information about your medicine. If you have any further questions or are not sure about anything, ask your doctor or pharmacist.
Leaflet dated 6th December 2021
Leaflet coded XXXXXXXXXX
Tildiem® is a registered trademark of Sanofi.
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.
5. how to store tildiem
- Keep out of the sight and reach of children.
- Do not use Tildiem after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other informationwhat tildiem contains each tablet contains 60mg of the active substance diltiazem hydrochloride.
- The other ingredients are lactose, macrogol 6000, hydrogenated castor oil and magnesium stearate.
What Tildiem looks like and contents of the pack
Package Leaflet: Information for the User
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes possible side effects not listed in this leaflet. See section 4.
- The name of this medicine is Zempt 60mg Modified Release Tablets but will be referred to as Zempt throughout the remainder of this leaflet.
-
1. What Zempt is and what it is used for
-
2. What you need to know before you take Zempt
-
3. How to take Zempt
-
4. Possible side effects
-
5. How to store Zempt
-
6. Contents of the pack and other information
1. what zempt is and what it is used for
Zempt contains a medicine called diltiazem hydrochloride. This belongs to a group of medicines called ‘calcium-channel blockers’. It works by making your blood vessels wider, which makes it easier for your heart to pump blood around the body. This helps to prevent the chest pain caused by angina.
Zempt is used for:
- Angina (chest pain)
- Stopping you getting angina in the future
2. what you need to know before you take zemptdo not take this medicine if:x you are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of zempt (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
X You are breast-feeding or planning to breast-feed (see below: ‘Pregnancy and breast-feeding’).
X You are having a medicine called dantrolene used for severe muscle spasms or severe fever (see below: ‘Other medicines and Zempt’).
X You have a very slow heartbeat – less than 50 beats per minute.
X You have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out of breath and have swollen ankles.
X You are already taking a medicine containing ivabradine for the treatment of certain heart diseases.
X You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker).
X You are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels. (see section: ‘Other medicines and Zempt).
X You are already taking a medicine containing asunaprevir used for the treatment of hepatitis C virus infection. (see section: ‘Other medicines and Zempt).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zempt.
Warnings and precautions
Talk to your doctor or pharmacist before taking your medicine if: a You have a history of heart failure, new shortness of breath, slow heartbeat or low blood pressure. Cases of kidney injury in patients with such conditions have been reported.
a You have any other problem with your heart, apart from angina or those described in the previous section.
a You are going to have an operation.
a You are at risk of mood changes, including depression.
A You are at risk of gut problems.
Your doctor will check you more closely particularly when you first start taking the tablets if:
a You are over 65 years old.
a You have liver or kidney problems.
a You have diabetes.
a You have or ever had asthma.
a You take any beta blocker medicines.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Zempt.
Other medicines and Zempt
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines you buy without a prescription, including herbal medicines. This is because Zempt can affect the way some other medicines work. Also some medicines can affect the way Zempt works.
In particular, do not take this medicine and tell your doctor if you are taking:
- Dantrolene (an infusion) used for severe muscle spasms or severe fever (called ‘malignant hyperthermia’).
- Medicines containing ivabradine used for the treatment of certain heart diseases.
- Medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of the lomitapide that may lead to an increase in the likelihood and severity of liver related side effects.
- Medicines containing asunaprevir used for the treatment of hepatitis C virus infection. Diltiazem may increase the concentration of the asunaprevir that may lead to an increase in the likelihood and severity of liver related side effects.
- Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol.
- Medicines used for an uneven heartbeat such as amiodarone and digoxin.
- Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate.
- Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin.
- Ciclosporin used to stop the rejection of organs after a transplant.
- Phenytoin and carbamazepine used for epilepsy.
- Antiplatelet medicines used to reduce the chance of blood clots forming, such as aspirin or clopidogrel.
- Iodinated contrast media (used for tests involving X-rays).
- Theophylline used for breathing problems.
- Lithium used for some types of mental illness.
- Medicines used for sleeplessness or anxiety, such as triazolam or midazolam.
- Methylprednisolone used for inflammation.
- Cilostazol used for intermittent cramp-like pain in your legs when you walk caused by insufficient blood supply in your legs.
- Rifampicin used for tuberculosis.
- Medicines for stomach ulcers such as cimetidine and ranitidine.
Zempt with food and drink
It is advisable to limit the amount of grapefruit juice you drink while taking Zempt as it can increase the blood levels of the active ingredient diltiazem and may increase your chance of getting side effects. If you are concerned you should stop drinking grapefruit juice and consult your doctor.
Pregnancy and breast-feeding
- You should not take Zempt if you are pregnant, might become pregnant or think you may be pregnant. This is because Zempt can cause problems for your baby. Talk to your doctor if you might be pregnant.
- Do not breast-feed if you are taking Zempt. This is because small amounts may pass into mother's milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.
Zempt contains:
- Lactose. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicine.
- Hydrogenated castor oil. May cause stomach upset and diarrhoea.
3. how to take zempt
Always take Zempt exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Take this medicine by mouth.
- If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
- The usual dose is one tablet three times a day.
- Two tablets three times a day or
- Two tablets four times a day.
- The usual dose is one tablet twice a day.
- Zempt should not be given to children.
If you take more Zempt than you should
If you take more tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, shortness of breath, fainting, an unusually fast or slow heartbeat, slurred speech, confusion, coma, sudden death and decrease of kidney function.
If, in an emergency situation, the patient is treated quickly sudden death is not only the potential outcome.
If you forget to take Zempt
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zempt
Keep taking Zempt until your doctor tells you to stop. Do not stop taking them just because you feel better. If you stop, your illness may get worse.
Tests
Your doctor may do regular tests while you are taking this medicine. These might include a check on your heart and blood tests to check on your liver and kidneys.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Zempt can cause side effects although not everyone gets them.
Stop taking and see a doctor or go to a hospital straight away if: Frequency unknown (cannot be estimated from the available data)
- You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
- You have a red or lumpy skin rash, swollen eyelids, face, lips, throat, or tongue, difficulty in swallowing.
- Your asthma gets worse.
- You have difficulty breathing, wheezing, tightness in the chest (called ‘bronchospasm’).
- You get blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be an illness called ‘Stevens-Johnson syndrome’.
- You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may feel generally unwell and have a fever, chills and aching muscles. This could be an illness called ‘Toxic Epidermal Necrolysis’.
- You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiforme’.
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment: Common (affects less than 1 in 10 people)
- Slow or uneven heartbeat
- Very fast, uneven or forceful heartbeat (palpitations)
- Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’).
- Being short of breath, feeling tired along with swollen ankles and legs. This could be signs of heart failure.
- Unusual movements of the tongue, muscle spasms in your face, rolling eyes and trembling.
- High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (called ‘hepatitis’).
- Passing large amounts of urine, excessive thirst and having a dry mouth or skin. These may be signs of high blood sugar (hyperglycaemia).
- Get sunburnt easier, and which may be more severe than in someone not taking Zempt. You should use sun protection whilst taking this medicine.
- Breast enlargement in men.
Tell your doctor as soon as possible if you have any of the following side effects:
Very common (affects more than 1 in 10 people)
- Swelling of the lower legs
- Indigestion, stomach pain, constipation and diarrhoea
- Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure)
- Dry mouth
- Itchy, lumpy rash (called ‘urticaria’)
Frequency unknown (cannot be estimated from the available data)
- Swollen gums
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (affects less than 1 in 10 people)
- Headache
- Flushing (feeling of warmth)
- Feeling sick (nausea) or being sick (vomiting)
- General feeling of being unwell
- Weakness or tiredness
- Feeling dizzy
- Skin redness
- Difficulty sleeping
- Mood changes, including depression
- Bleeding or bruising under the skin
Blood tests
Zempt can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
Manufactured by
Sanofi Winthrop Industrie, 30–36 Avenue Gustave Eiffel, Tours, France.
Procured from within the EU by the Product Licence Holder: MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0682
POM
This leaflet does not contain all the information about your medicine. If you have any further questions or are not sure about anything, ask your doctor or pharmacist.
Leaflet dated 6th December 2021
Leaflet coded XXXXXXXXXX
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.
5. how to store zempt
- Keep out of the sight and reach of children.
- Do not use Zempt after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
- This medicinal product does not require any special storage conditions.
- If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other informationwhat zempt contains each tablet contains 60mg of the active substance diltiazem hydrochloride.
- The other ingredients are lactose, macrogol 6000, hydrogenated castor oil and magnesium stearate.
What Zempt looks like and contents of the pack
Zempt tablets are white, round, biconvex tablets engraved with ‘DTZ 60’ on one side and a breakline on the reverse.
The tablets are provided in blister packs containing 50, 90 or 100 tablets.